SVP, Biometrics

Role Overview

• Reporting to the Chief Medical Officer, the SVP Biometrics will be accountable for biometrics activities for all programs from IND-enabling to registration and launch.
• This includes leadership of the Biostatistics, Statistical Programming & Analysis, and Clinical Data Management functions.
• This role requires hands-on execution as well as oversight of internal and external staff.
• In addition, this person will represent the Biometrics function on the Erasca leadership team and in cross-functional discussions and decision making.
• Build, maintain, and develop a high performing team across Biostatistics, Statistical Programming, and Clinical Data Management.
• Ensure systems, capabilities and resources are in place that optimize the design, conduct, analysis and interpretation of clinical and nonclinical data for all programs.
• Demonstrate technical excellence, delivering advanced biometric strategies across the portfolio.
• Act as the subject matter expert for biometrics, advising senior management, development, and clinical operations teams on current biostatistics methodology and tools in drug development.
• Collaborate with VP, Biostatistics, to ensure statistical analysis and submission datasets meet regulatory requirements.
• Collaborate with VP, Statistical Programming & Analysis, to ensure the intended analyses are performed, and analysis data sets and their specifications are in place.
• Collaborate with Sr Director, Clinical Data Management, to provide support to clinical study teams on the collection, interpretation and reporting of clinical data.
• Provide input on key development documents, clinical protocols, study reports, IBs, INDs, NDAs, and labeling for all products.
• Support preparations for interactions with regulatory agencies and provide guidance to ensure high quality preparation of Regulatory Authority documents.

Requirements

• Minimum of 15 years relevant experience in the pharmaceutical or biotechnology industry, ideally including both large and small company experience.
• PhD degree in statistics or biostatistics required.
• A hands on and flexible leader, comfortable as a subject matter expert for biometrics as well as contributing at the leadership team and leading and managing highly accomplished function managers.
• Experience in oncology drug development required, ideally from FIH to registration.
• Direct experience leading and working in Biostatistics required as well as experience leading Statistical Programming and/or Clinical Data Management.
• Extensive knowledge of clinical research methodology and regulatory requirements as they relate to trial design and analysis.
• Good knowledge of ICH, FDA, and GCP regulations and guidelines; strong well-rounded technical skill, SAS, SDTM, and CDISC.
• Extensive experience negotiating successfully with health authorities.
• Excellent analytical and organizational skills.
• Track record of successfully working within individual protocols and across programs to design, drive, and execute statistical strategy.
• Proven ability to attract, develop, and manage top notch talent including a mix of internal and contingent staff.
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
• Executive leadership skills to educate and influence stakeholders and to add value in strategic business planning and decision-making.
• Effective interpersonal, communication, and influencing skills, including strong writing and presentation skills, with the ability to tailor communication style to diverse audiences and situations.
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
• Strong learning orientation, curiosity, and commitment to science and patients.

Tech Stack

• Google Cloud Platform

Benefits

• Paid Time Off
• Holiday
• Sick Leave
• Medical, Dental and Vision Plans
• Short
• and Long-Term Disability
• Basic and Voluntary Life/AD&D Coverage
• Flexible Spending Accounts (FSA, HSA, and Commute)
• Critical Illness and Accident Coverage
• Pet Insurance
• Employee Assistance Program
• 401(k) Plan with Erasca contribution
• Opportunity to participate in an Employee Stock Purchase Program